ACTS WHOSE PUBLICATION IS NOT OBLIGATORY  
COMMISSION DIRECTIVE 2009/159/EU  
of 16 December 2009  
amending, for the purpose of adaptation to technical progress, Annex III to Council Directive 
76/768/EEC concerning cosmetic products  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on European Union and to the 
Treaty on the Functioning of the European Union,  
Having regard to Council Directive 76/768/EEC of 27 July 
1976 on the approximation of the laws of the Member States 
relating to cosmetic products (  1 ), and in particular Article 8(2) 
thereof,  
After consulting the Scientific Committee on Consumer Safety,  
Whereas:  
(1) According to the safety assessment strategy for hair dye 
substances, it was agreed with the Member States and 
stakeholders that the date of 31 December 2007 would 
be appropriate for the submission to the Scientific 
Committee on Consumer Safety (hereinafter ‘SCCS’) of 
the scientific data on the reaction products formed by 
oxidative hair dye substances on the scalp and their 
safety for the consumer.  
(2) Presently, there are 31 hair dye substances which are 
provisionally allowed for use in cosmetic products until 
31 December 2009 under the restrictions and conditions 
laid down in Part 2 of Annex III to Directive 
76/768/EEC. The requested scientific data on the safety 
of reaction products formed by oxidative hair dye 
substances were submitted by the cosmetics industry to 
the SCCS before the agreed deadline of 31 December 
2007.  (3) The submitted safety data were evaluated by the SCCS. In 
January 2009, the SCCS concluded in its opinion that it 
is not in the position to finally assess the risk of reaction 
products of oxidative hair dyes due to the incompleteness 
of the dossier submitted by the industry. The cosmetics 
industry provided the missing data by the end of 
September 2009.  
(4) In view of the above, the risk assessment of the 
submitted additional data and the final opinion given 
by the SCCS on the safety of the reaction products will 
still require a period of time exceeding the provisional 
deadline of 31 December 2009 for the substances listed 
in Part 2 of Annex III.  
(5) Therefore, the definitive regulation of 31 hair dye 
substances listed in Part 2 of Annex III, on the basis of 
risk assessment of their reaction products, and its imple ­
mentation into the laws of Member States will not take 
place before the provisional deadline. Consequently, their 
provisional use in cosmetic products under the current 
restrictions and conditions laid down in Part 2 of Annex 
III should be extended. The new prolonged deadline of 
31 December 2010 is considered sufficient for the 
definitive regulation of these substances.  
(6) Directive 76/768/EEC should therefore be amended 
accordingly.  
(7) The measures provided for in this Directive are in 
accordance with the opinion of the Standing 
Committee on Cosmetic Products,  
HAS ADOPTED THIS DIRECTIVE:  
Article 1  
Amendment to Directive 76/768/EEC  
In reference numbers 3, 4, 5, 6, 10, 11, 12, 16, 19, 20, 21, 22, 
25, 26, 27, 29, 31, 32, 33, 34, 35, 36, 37, 38, 39, 44, 48, 49, 
50, 55, and 56 of column g in Part 2 of Annex III to Directive 
76/768/EEC, the date ‘31.12.2009’ is replaced by ‘31.12.2010’.EN 18.12.2009 Official Journal of the European Union L 336/29  
( 1 ) OJ L 262, 27.9.1976, p. 169.Article 2  
Transposition  
1. Member States shall adopt and publish, by 31 December 
2009 at the latest, the laws, regulations and administrative 
provisions necessary to comply with this Directive. They shall 
forthwith communicate to the Commission the text of those 
provisions.  
They shall apply those provisions from 1 January 2010.  
When Member States adopt those provisions, they shall contain 
a reference to this Directive or be accompanied by such a 
reference on the occasion of their official publication. Member 
States shall determine how such reference is to be made.  
2. Member States shall communicate to the Commission the 
text of the main provisions of national law which they adopt in 
the field covered by this Directive.  Article 3  
Entry into force  
This Directive shall enter into force on the third day following 
its publication in the  Official Journal of the European Union . 
Article 4  
Addressees  
This Directive is addressed to the Member States.  
Done at Brussels, 16 December 2009.  
For the Commission  
The President  
José Manuel BARROSOEN L 336/30 Official Journal of the European Union 18.12.2009